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Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

This study has been terminated.
(The alternative laparoscopic chole, has so little morbidity very few patients opt for a transvaginal approach when presented with the alternative)
Information provided by (Responsible Party):
David W. Rattner, MD, Massachusetts General Hospital Identifier:
First received: May 27, 2009
Last updated: October 29, 2012
Last verified: October 2012
To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution.

Condition Intervention Phase
Procedure: Laparoscopic-assisted transvaginal cholecystectomy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The safety and efficacy of the procedure [ Time Frame: one year ]

Secondary Outcome Measures:
  • Post-operative pain [ Time Frame: one year ]
  • Time to return to work [ Time Frame: one year ]
  • Time to return to daily activities [ Time Frame: one year ]

Enrollment: 3
Study Start Date: November 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Laparoscopic-assisted transvaginal cholecystectomy
    Trans-vaginal Cholecystectomy with Laparoscopic Assistance

Ages Eligible for Study:   26 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Females who are postmenopausal or who no longer wish to bear children
  • Females >25 years old and <65 years old
  • Diagnosis of biliary disease requiring cholecystectomy
  • American Society of Anesthesiology (ASA) Class I or II
  • Females who are able to understand and willing to sign an informed consent document

Exclusion Criteria:

  • Pregnancy
  • BMI >= 30
  • Patients who are still interested in childbearing
  • Patients taking immunosuppressive medications or who are immunocompromised
  • Patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid)
  • Patients with suspicion of gallbladder cancer
  • Patients with history of previous open abdominal surgery
  • Patients with untreated common bile duct stones
  Contacts and Locations
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Please refer to this study by its identifier: NCT00910325

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: David W Rattner, MD Massachusetts General Hospital
  More Information

Responsible Party: David W. Rattner, MD, Chief, Division of General and Gastrointestinal Surgery, Massachusetts General Hospital Identifier: NCT00910325     History of Changes
Other Study ID Numbers: 2008p001938
Study First Received: May 27, 2009
Last Updated: October 29, 2012

Keywords provided by Massachusetts General Hospital:
Natural Orifice Surgery
Laparoscopic- Assisted

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical processed this record on May 25, 2017